The pork industry earlier this week said it wants to get the Food and Drug Administration (FDA) out of regulating livestock genome editing. But unless pigs fly, that possibility seems pretty remote.
That’s because FDA is the center post of America’s food safety-based regulation of genome editing of plants and animals, and that’s unlikely to change. But the National Pork Producers Council (NPPC) has depicted the FDA as an obstacle genetic approvals, slowing the industry from combatting animal diseases and potentially losing “elite breeding” to foreign competitors like Argentina, Brazil or Canada.
FDA does not see it that way.
“FDA is an important partner in advancing promising agricultural biotechnology innovations, FDA’s Anna Abram told Food Safety News. “FDA does not regulate an animal as a drug, but instead our framework evaluates intentional genomic alternations (IGAs) in animals based upon the risk they pose to the animal and human health. Making sure these products are safe and perform as expected is critical to maintaining consumer and commercial confidence in them and realizing their potential benefits for human and animal health.”
Abram is FDA’s Deputy Commissioner for Policy Legislation and International Affairs.
“FDA’s science and risk-based approach is flexible: FDA does not intend to enforce investigational and approval requirements for IGAs in animals that pose minimal risk,” Abram continued. ” For those IGAs that go through the approval process, under our Veterinary Innovation Program, we work closely with developers to support an efficient and predictable pathway to approval. Most importantly, this approach protects people and animals, while also promoting consumer confidence in the products and these innovations.”
Just last week, FDA posted a list of IGAs in animals that after a review of risk factors were found to be low-risk and not requiring further enforcement of approval requirements. Included were animals of food-producing species intended for use as models of disease iike mini swine, certain aquarium fish, and IGAs to cause fish to become fluoresce/
FDA says that for IGAs that must go through the approval process, its goal is to ensure safety of the animal and the food derived from it while making sure the genomic alteration does what it is intended to do and the product is safe and effective.
Some factors that will come into play are going to make it very difficult for the pork industry to remove itself from FDA jurisdiction when it comes to livestock genome editing. These include:
History: Congress often divides responsibility among agencies and departments The current framework dates back to 1986 when the FDA, Environmental Protection Agency (EPA) and USDA’s Animal and Plant Health Inspection Service (APHIS) got their assignments.
Mission: FDA’s mission is food safety driven. It responsible for human food and animal feed, policing labels, and plant-derived food and feeds.
Law: The FDA reviews intentional genomic alterations (IGAs) under the authority found in the Food, Drug & Cosmetic Act. It provides the legal mandate for FDA to assess for food safety and the safety of the altered animal. It also determines the effectiveness of the alteration, meaning does it do what the developer or sponsor claims it will do.
Federal Regulations: APHIS, through its Biotechnology Regulatory Services (BRS), has a role with genetically engineered plants, and ERA has a purpose, most involving pesticides. But FDA is also responsible for the safety of plant-derived foods and feeds and serves as America’s top biotechnology regulator.
Approach: “We also want to help beneficial innovations advance to consumers,” says an FDA spokesman. “That’s why our approach to regulating IGAs in animals is risk-based and grounded in sound science. We aim to tightly tailor regulation to align with risk to make sure the process is efficient but still provides consumer safety assurances.”
Experience: The first approved IGA in animal for food use in the world was FDA’s approval of the AquAdvantage Salmon, a GE Atlantic salmon. The agency’s experience as a regulator of biotechnology is recognized worldwide. Because of that experience, the FDA has decided that IGAs in animals that pose minimal risk won’t require all the investigational and approval requirements. It also intends to use enforcement discretion for IGAs in laboratory animals t used for research, but not producing food.
Last April when he was announcing the GE salmon approval, former FDA Commissioner Scott Gottlieb spoke about the agency’s relationship with industry.
“At the U.S. Food and Drug Administration, we’re committed to helping food developers bring biotechnology innovations to market while at the same time providing consumers with confidence that foods available for purchase in the U.S. – whether developed using traditional breeding techniques or biotechnology – meet the FDA’s high safety standards, Gottlieb said.
“The FDA encourages developers of IGAs in animals to approach the agency early in its research and development phase to discuss the specific risk profile of the proposed product and the regulatory pathway for commercialization. The FDA routinely works with sponsors early and often to provide greater clarity in the regulatory process, encourage development and research, and support an efficient and predictable pathway to approval.
FDA did lose its place in inspecting domestic and foreign catfish to USDA in 2013 but that took two Farm Bills and more than a decade to play out. USDA now leads catfish inspections under an agreement with FDA.
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